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A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial

RecruitingNAAges 18 Years - anyAllUniversity of Pittsburgh
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In plain words

What the trial is, and whether it could suit you

The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged โ‰ฅ 18 years 2. Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements \>12 hours apart) Exclusion Criteria: 1. AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy 2. Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as: 1. Baseline estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m2 2. Previous kidney transplant recipient 3. On chronic dialysis 3. Acute urinary obstruction with rapid kidney function improvement following relief of obstruction 4. Index hospitalization involving nephrectomy 5. Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant 6. Continued dialysis dependence at time of discharge 7. Previous (within 6 months) or new referral to a nephrologist for care specifically for: 1. Previous or new diagnosis of glomerulonephritis 2. Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome) 3. Active treatment for acute interstitial nephritis 8. Non-kidney end-organ failure: 1. Class IV congestive heart failure 2. Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) \> 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams 3. End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension) 9. Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma 10. Primary goal of care is palliation: life expectancy \<6 months 11. Pregnancy 12. Vulnerable populations 1. Persons incarcerated 2. Persons institutionalized 13. Inability to provide informed consent a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM) 14. Concurrent enrollment in a separate greater than minimal risk interventional trial 15. Inability to participate in either in-person or remote visits a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF) 16. Discharge to long-term acute care facility or other hospital-based location
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What it tests

  • Study Physician/Advance Practice Provider
  • Nurse Navigator
  • Pharmacist
  • Patient Education
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Where

9 sites
University of Alabama at Birmingham
Birmingham, United States
Yale University
New Haven, United States
Cleveland Clinic Weston Hospital
Weston, United States
University of Maryland
Baltimore, United States
Johns Hopkins University
Baltimore, United States
MetroHealth
Cleveland, United States
Cleveland Clinic Foundation
Cleveland, United States
Nashville VA Medical Center
Nashville, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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